NHRA Introduces Enhanced Service for Medicine Registration Changes

Manama: In a significant move aimed at improving the quality of service and streamlining procedures, the National Health Regulatory Authority (NHRA) has introduced a new service to facilitate changes to registered medicines. This development is part of the government's broader initiative to enhance customer experience in the updating and amending of medicine data while adhering to regulatory standards and pharmaceutical product registration requirements.

According to Bahrain News Agency, the enhanced service significantly reduces the time needed to complete the process and strengthens review procedures to ensure safety and quality. This is achieved through the new service designed for major and minor changes to registered medicines, allowing for the approval of amendments after a thorough review of documents and supporting data related to the product's quality, safety, and efficacy.

The improvements also see a reduction in service completion time from 45 to 40 working days for major changes, and from 45 to just 7 working days for minor changes. The process involves electronic submission of applications, document attachment, and fee payment, with subsequent review and approval via the "Adweya" system. Additionally, service levels and the number of required approvals have been reduced, and service information has been standardized across all platforms to boost efficiency and transparency.

Dr. Ahmed Mohammed Al Ansari, Chief Executive of NHRA, stated that this development aligns with the authority's goal of advancing institutional performance through modern technologies. This supports pharmaceutical oversight and enhances procedural reliability, aligning with best regulatory practices in the health sector.

Dr. Al Ansari further emphasized that the enhancements reflect NHRA's commitment to improving services by reducing time and effort for pharmaceutical companies, which in turn enhances procedural efficiency and ensures the safe and efficient circulation of pharmaceutical products in compliance with regulatory standards.

These changes are part of a larger government effort to overhaul and re-engineer services, with over 1,300 government services documented, translated, and published. Approximately 800 services are undergoing development across various government sectors, based on feedback from the National System for Suggestions and Complaints "Tawasul," investor feedback, and evaluations from secret shopper reports.

These initiatives are pivotal in improving procedural efficiency, enhancing service quality, and strengthening user experience, while supporting the government's digital transformation efforts.

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